European Council decision delights borderline device companies
This article was originally published in Clinica
Executive Summary
There is good news - at least for the moment - for manufacturers of medical devices on the drug/device borderline, with the publication of the Council of Ministers' political agreement on the review of pharmaceutical regulations. The text makes it clear that the scope extends only to products whose action is primarily pharmacological, thus specifically excluding some the products on the borderline such as drug-coated stents.